NCT03070379

Brief Summary

At recent, the number of patients who underwent sedated esophagogastroduodenoscopy has been on the increase. For such patients, whether topical pharyngeal anesthesia is needed remains to be controversial. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline for non-anesthesiologist administration of propofol for GI endoscopy have not made any recommendation, because the role of pharyngeal anesthesia during propofol sedation for upper digestive endoscopy has not been assessed. Our study aimed at investigating whether topical lidocaine pharyngeal anesthesia could benefit patients who underwent esophagogastroduodenoscopy under propofol sedation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

February 23, 2017

Last Update Submit

March 2, 2017

Conditions

Esophagogastroduodenoscopy

Outcome Measures

Primary Outcomes (1)

  • Immediate throat pain score

    Immediate throat discomfort will be recorded, and pain score (0 no pain - 10 most painful) will be given by the patients.

    1 day

Secondary Outcomes (3)

  • Throat discomfort 1 day after the procedure

    1 day

  • Adverse events

    1 day

  • Satisfaction score

    1 day

Study Arms (2)

Experimental group

EXPERIMENTAL

Topical lidocaine pharyngeal anesthesia was performed.

Procedure: Topical lidocaine pharyngeal anesthesia

Control group

NO INTERVENTION

No topical lidocaine pharyngeal anesthesia was performed.

Interventions

Topical lidocaine pharyngeal anesthesiaPROCEDURE

Topical pharyngeal anesthesia by lidocaine was administrated 4-5 min before propofol sedation in patients who underwent esophagogastroduodenoscopy.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥18 Years
  • Patients who have indications for esophagogastroduodenoscopy
  • American Society of Anesthesiology risk class 1, 2 or 3

You may not qualify if:

  • Patients \<18 years
  • Patients with thrombocytopenia (platelet count \< 50,000/microL) or elevated International Normalized Ratio (INR \> 1.5)
  • Hemodynamic instability
  • Pregnancy and lactation
  • Patients who are unable or unwilling to give an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital to Academy of Military Medical Sciences

Beijing, 100071, China

RECRUITING

Related Publications (3)

  • Heuss LT, Hanhart A, Dell-Kuster S, Zdrnja K, Ortmann M, Beglinger C, Bucher HC, Degen L. Propofol sedation alone or in combination with pharyngeal lidocaine anesthesia for routine upper GI endoscopy: a randomized, double-blind, placebo-controlled, non-inferiority trial. Gastrointest Endosc. 2011 Dec;74(6):1207-14. doi: 10.1016/j.gie.2011.07.072. Epub 2011 Oct 13.

    PMID: 22000794BACKGROUND

  • Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11.

    PMID: 21072716BACKGROUND

  • Sun X, Xu Y, Zhang X, Li A, Zhang H, Yang T, Liu Y. Topical pharyngeal anesthesia provides no additional benefit to propofol sedation for esophagogastroduodenoscopy: a randomized controlled double-blinded clinical trial. Sci Rep. 2018 Apr 27;8(1):6682. doi: 10.1038/s41598-018-25164-7.

    PMID: 29703990DERIVED

Study Officials

  • Yang Liu, M.D., Ph.D.

    Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaotian Sun, M.D., Ph.D.

CONTACT

+86-010-66947473xiaotian-sun@hotmail.com

Yang Xu, M.D., Ph.D.

CONTACT

+86-010-66947473yanuoda531@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2017

First Posted

March 3, 2017

Study Start

February 20, 2017

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)